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The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of: - Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip - Correction of functional deformity - Avascular Necrosis - Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur - Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation without bone cement.

The previously cleared Cardo Medical Hip System consists of: - commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems, - cobalt chrome (CoCr) femoral heads - commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells - ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts and - titanium alloy (Ti-6Al-4V) bone screws. The proposed devices are a line extension to the previously cleared system to add 36mm femoral heads and 36mm inserts.

When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: - Degenerative arthritis in the distal femur and patella; . - A history of patellar dislocation or fracture; . - Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis; - Post-traumatic loss of knee joint confiquration and function: . - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability; - Revisions of previous unsuccessful knee replacement or other procedure. . Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint: . - Absent or non-functioning posterior cruciate ligament. . The patella components are single use only and intended for implantation with bone cement.

The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE with pegs on the non-articulating surface. The surgeon uses the components to resurface the patella during either a patella-femoral replacement or a total knee replacement. The device is designed for cemented fixation only.

The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with: - Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); - Trauma (including fractures) . - Tumor ● - Deformity (defined as kyphosis, lordosis or scollosis) . - Pseudoarthrosis . - Failed previous fusions. ● The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

The Cardo Medical Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine. The modified system includes the addition of a fixed angle cervical screw as an option for the surgeon.